Table 3.
Incidence of adverse events (AEs) and adverse reactions to vaccine (ARVs) in subjects aged 6–35 months by system organ class (SOC)
| Adverse eventa | Adverse reaction to vaccinea | |||||
|---|---|---|---|---|---|---|
| Number of subjects with AE (%) | 95% confidence interval (lower, upper) | Number of AEs | Number of subjects with ARV (%) | 95% confidence interval (lower, upper) | Number of ARVs | |
| Infections and infestations | 98 (14.26) | (11.74, 17.11) | 126 | 0 (0.00) | (0.00, 0.54) | 0 |
| General disorders and administration site conditions | 43 (6.26) | (4.57, 8.34) | 50 | 24 (3.49) | (2.25, 5.15) | 28 |
| Respiratory, thoracic and mediastinal disorders | 24 (3.49) | (2.25, 5.15) | 32 | 0 (0.00) | (0.00, 0.54) | 0 |
| Gastrointestinal disorders | 19 (2.77) | (1.67, 4.29) | 19 | 0 (0.00) | (0.00, 0.54) | 0 |
| Skin and subcutaneous tissue disorders | 15 (2.18) | (1.23, 3.58) | 15 | 1 (0.15) | (0.00, 0.81) | 1 |
| Psychiatric disorders | 3 (0.44) | (0.09, 1.27) | 3 | 0 (0.00) | (0.00, 0.54) | 0 |
| Injury, poisoning and procedural complications | 1 (0.15) | (0.00, 0.81) | 1 | 0 (0.00) | (0.00, 0.54) | 0 |
| Nervous system disorders | 1 (0.15) | (0.00, 0.81) | 1 | 0 (0.00) | (0.00, 0.54) | 0 |
| Vascular disorders | 1 (0.15) | (0.00, 0.81) | 1 | 0 (0.00) | (0.00, 0.54) | 0 |
| Total | 149 (21.69) | (18.66, 24.96) | 248 | 25 (3.64) | (2.37, 5.33) | 29 |
AE adverse event, ARV adverse reaction to vaccine
aThe list of detailed AEs and ARVs by SOC and preferred term is presented in Supplementary Table 9
Number of subjects with AE (%) = (Number of subjects with AE in each category) / (Number of subjects in safety analysis set) x 100
Number of subjects with ARV (%) = (Number of subjects with ARV in each category) / (Number of subjects in safety analysis set) x 100
95% confidence interval for the percentage of subjects with AE/ARV was calculated by exact methods.
Coding dictionary: Medical Dictionary for Regulatory Activities (MedDRA) 24.0